Senior Specialist, Field Quality QA Operations

Senior Specialist, Field Quality QA Operations

Position:
Senior Field QA Specialist

This role maintains quality oversight, ensures GMP compliance, and supports real‑time quality assurance during manufacturing operations. Responsibilities include batch record reviews, on‑floor exception reviews, GMP area walkthroughs, and support of return‑to‑service (RTS) activities.

Monday – Friday, 2 p.m. – 10:30 p.m. (Onsite Afternoon Shift)

• Provide quality floor support for complex manufacturing activities.
• Review manufacturing batch production records to support product release per specifications and SOPs.
• Conduct GMP area walkthroughs to document observations and concerns.
• Train new team members on routine facility Quality tasks.
• Support return‑to‑service walkthroughs and manufacturing inspection readiness per procedures.
• Ensure all electronic and paper documentation requiring QA review complies with corporate and site procedures, cGMP regulations, and industry guidelines.

• Knowledge of biotech bulk and finished product manufacturing, analytical testing.
• Understanding of US and EU cGMP regulations and guidance.
• Experience with electronic batch record systems (e.g., DeltaV) and other laboratory and inventory systems.
• Ability to interact with staff across Quality, Supply Chain, Digital Plant, Site Engineering, and Manufacturing.
• Judgment in selecting methods and techniques within defined policies.
• Ability to handle assignments requiring defined processes with appropriate supervision.

• Bachelor’s degree in science, engineering, biochemistry, or related discipline (or equivalent). Preferred.
• 4 years of Quality Assurance experience in the pharmaceutical or medical device industry.
• Experience reviewing batch records.

• Work performed in a modern manufacturing facility with exposure to pressurized liquids/gases, steam, and hazardous chemicals.
• PPE required, including gowning for clean room environments.

Devens – MA – US: $89,530 – $108,490 (full‑time basis). Incentive cash and stock opportunities may be available.

• Health coverage (medical, pharmacy, dental, vision)
• Well‑being support programs
• 401(k) plan, disability, life insurance, and supplemental health benefits
• Paid time off, holiday schedule, and global shutdown during Christmas–New Years

BMS is an equal‑opportunity employer. We welcome applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.